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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K875171
Device Name J-CATH(TM)
Applicant
HDC CORP.
2551 CASEY AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact RONALD L COLEMAN
Correspondent
HDC CORP.
2551 CASEY AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact RONALD L COLEMAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/17/1987
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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